As the number of elderly people increase in the United States and their lifespans extend there is an ever increasing need for newer and safer pharmaceutical products. As such, there is a need for new drugs and medical devices to be approved more rapidly. With the mapping of the human genome it is estimated that drug targets and drugs will multiply tenfold, necessitating more clinical testing. In fact, The Pharmaceutical Research and Manufacturers of America (PhRMA) states that all drugs currently on the market are based on about 500 different targets. They expect this number to increase 600-2000%, to 3,000 to 10,000 drug targets in the coming years. However, such medical advances are outrageously expensive and have necessitated changes throughout the industry.
It is estimated to cost $880 million to bring one new drug to market. And it is estimated that the average pharmaceutical company has 70 new drugs in development. This has forced the pharmaceutical companies to consolidate for the purpose of underwriting the prohibitive expense of bringing a drug to market. The average drug takes 10 to 12 years to bring to market and must negotiate a series of 3 clinical trials before approval by the Food and Drug Administration (FDA) can even be granted, leaving 8 to 10 years on a drug patent to recoup costs and turn a profit. Factoring in the governmental and managed care cost containment pressures, the pharmaceutical companies must produce one blockbuster medicine every 18 months to survive.
In summary, the pharmaceutical companies are in a position where they are producing more new drug compounds than ever before; they are about to lose the patents on many of their highly profitable, blockbuster, drugs; and they are being squeezed by the managed care industry. It is therefore critical for the pharmaceutical companies to discover, test and market the maximum number of new drugs in the minimum amount of time.
In order to speed up this process, business efficiencies are being applied to the previously haphazard clinical trials process. According to a Tufts University study, each day a study is late a pharmaceutical company can lose $1.3 million in lost prescription drug sales and it can be as high as $10 million for a blockbuster drug. Clinical trials are for the most part paper-based; necessarily cumbersome; and slow to monitor, process and store. One of the key factors affecting the time it takes to complete a clinical trial or study is the time it takes to recruit, screen and refer patients to the study. Only when the study is completely populated with patients can testing begin. Currently, the haphazard methods to recruit patients can take up to a year and thus, it becomes no surprise that 75% of all clinical studies are completed late.
There are a number of web-based clinical trial management software programs which plan, administer, and process trials for pharmaceutical companies. Although less than 15% of drug trials are e-clinical trials, this number is expected to increase to 50% or more in the next few years. Such trials will allow realtime monitoring of trials for adverse drug reactions and quality control, as well as more efficiently, move and process the prodigious amount of data generated. However, one area which still has not been adequately addressed is recruitment.
Traditionally, patients for studies have been enrolled from an investigator's clinic or practice, via referrals or by advertising. The only known prior art publication that addresses this problem is entitled Recruiting A Patient Into A Clinical Trial, Pub. No. US 2002/0099570 A1 by Knight. Basically, Knight discloses how a patient with a particular disease may find a relevant study using a computer, a web browser and Internet connection. Otherwise, the need for recruiting patients is served by databases of patients available for drug trials, or by programs that flag key words on dictated summaries using a search engine for evaluation for eligibility in studies, or by web-based patient enrollment programs. There are a number of websites where patients may do a preliminary application for eligibility and thereby enroll by this means.
The known prior art does not systematically search all available places that patients may be found for drug trial enrollments. In particular, those websites that deal only with investigators comprise only 5% of all physicians, and a corresponding number of patients. Knight's method does not systematically search for and find patients. It is believed that none of the known systems have a way to tap into and motivate the 95% of non-research performing physicians to find and enroll their patients into studies. And the known systems depend on patients having a computer with internet access. The method that searches dictations and flags patients is basically used in the offices of physicians with large practices who do research. These physicians are then paid for each patient found and for administering the study on that patient. However, these physicians are usually specialists who depend on referrals and it may take months for newly diagnosed patients to see the specialist.
Therefore, based upon the foregoing, there is a need for a process that will tap a larger pool of patients more systematically, and that will identify prospective patients at an earlier stage of their ailment before they see the appropriate specialist. And there is also a need to accurately estimate the cost of doing the study and distribute payments to the participating physicians.